UltrasouNd-guided Percutaneous Intercostal Nerve Cryoneurolysis for Analgesia Following Traumatic Rib Fracture

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorSunnybrook Health Sciences Centre

About this trial

Traumatic rib fractures (i.e., broken ribs caused by a physical injury) are common and very painful. They also often lead to serious complications, more time spent in hospital, and can even lead to death. Even after rib fractures have healed, they can lead to long-term pain and a lower quality of life.

A technology called cryoneurolysis, which acts to freeze nerves causing pain using a small tool which can turn very cold, is a promising new way to manage rib fracture pain. This study is a test with a small number of people to see if it is feasible to use this technology for patients with rib fractures. If this is successful, we will recruit more people for a larger study to see if cryoneurolysis, along with standard pain control techniques, is better at stopping pain, compared to just the normal techniques alone. Participants in our study will be asked to rate their pain, and record pain medications that they take for 3 months after their pain procedure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥18

Unilateral traumatic rib fractures (3 to 8)

Candidate for ESP block catheter

Within 48hrs of admission to hospital

Disqualifiers

Lack of patient consent; unlikely to comply with follow up

Unable to use Patient Controlled Regional Analgesia (Ventilated/sedated patients or Moderate to severe traumatic brain injury)

Chronic pain (opioid use > 30mg oral morphine equivalent per day)

Substance use disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cryoneurolysis

    Procedure/Surgery

    Cryoneurolysis will be performed on the intercostal nerve associated with each fractured rib using a handheld cryoneurolysis machine (Iovera). Cryoneurolysis will consist of two 103 second cycles (includes cooling, ice ball formation and warming time) per rib fracture level. Ultrasound guidance will be used to identify appropriate rib fracture levels and to target the device tip in real time. All participants will also receive standard multimodal analgesia and ESP catheter infusion.

  • Sham Cryoneurolysis

    Procedure/Surgery

    Participants in the control group will receive sham CN (i.e., application of device without skin puncture or activation of unit) to maintain participant blinding. All participants will also receive standard multimodal analgesia and ESP catheter infusion.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Cryoneurolysis GroupExperimental treatment 1 intervention
Group B: Standard Care GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants randomized over an 8 month period

Goal of 3 participants per month for 8 months

Time frame
Entire pilot study (approximately 8 months)
2

Number of participants able to adhere to the protocol

Goal of \> 90%

Time frame
Entire pilot study (approximately 8 months + 3 month follow-up)
3

Number of participants able to adhere to the follow-up

Goal of \> 90%

Time frame
3 month follow-up
4

Rate of Adverse events

Ensure no adverse events (short or long term) associated with CN

Time frame
3 month follow-up

Secondary outcomes

1

Pain Severity during deep inspiration 24 hours post ESP catheter placement

Pain measured using Numeric Pain Rating Scale

Time frame
24 hours post placement of ESP catheter
2

Time to discontinuation of ESP catheter

Based on when patient has met criteria for APS discharge or pain is controlled such that PCRA use is \< 2 boluses over 12 hrs and NRS \< 3 with deep breathing and coughing

Time frame
Until ESP catheter removal (usually < 7 days)
3

ESP catheter use

Cumulative volume of local anesthetic solution used via ESP catheter patient controlled reginal analgesia

Time frame
Until ESP catheter removal (usually < 7 days)
4

Opioid consumption in hospital and after discharge

Determined from medical records (in-hospital) and via a daily pain diary (post-discharge). Calculated in Oral Morphine Equivalents.

Time frame
Daily for 90 days after block placement

Other outcomes

1

Pain Intensity

As measured using NRS-11, at rest and during deep inspiration

Time frame
1h and 48h, post block placement, daily in hospital, weekly post discharge and at 1 week follow-up

Sponsors and contacts

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